Half-normal Saline in Atrial Fibrillation Ablation

NCT03498586 | Completed

• 1 other identifier: TCAI_HNS_AF
• Study Type: interventional
• Target: 99
• Locations: 2 countries
• Sites: 2

Brief Summary

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• total radiofrequency ablation time, and total procedure time

  intraprocedural

• acute pulmonary veins, and left atrial appendage (if applicable) reconnection

  intraprocedural

• freedom from atrial tachycardia/atrial fibrillation > 30 seconds without antiarrhythmic drugs

  1 year

Secondary Outcomes (2)

• freedom from atrial tachycardia/atrial fibrillation > 30 seconds with or without antiarrhythmic drugs

  1 year

• long-term pulmonary veins, left atrial appendage (if applicable), and coronary sinus (if applicable) reconnection

  in case of a repeat procedure performed during the study follow-up (an average of 1 year)

Other Outcomes (2)

• procedure-related complications

  periprocedural (at the time of the procedure and up to 1 month)

• hyponatremia

  periprocedural (at the time of the procedure and up to 1 month)

Study Arms (2)

Half-normal saline

EXPERIMENTAL

Drug: Half-normal saline

Normal saline

ACTIVE COMPARATOR

Drug: Normal saline

Interventions

Half-normal saline DRUG

Use of half-normal saline as an irrigant for open-irrigated ablation catheters

Half-normal saline

Normal saline DRUG

Use of normal saline as an irrigant for open-irrigated ablation catheters

Normal saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female between 18 and 75 years of age at the time of enrollment
• undergoing first-time radiofrequency ablation for atrial fibrillation
• written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

You may not qualify if:

• robotic-guided atrial fibrillation ablation
• baseline hyponatremia (serum sodium level \< 135 mEq/L)
• pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
• presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (2)

Texas Cardiac Arrhythmia Institute, St. David's Medical Center

Austin, Texas, 78705, United States

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Institute, St. David's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 13, 2018
• Study Start: May 2, 2018
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

US (1); CA (1)